MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. MULTI-DRUG 3 PANEL SCREEN TEST; ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES

Model Number	DOA-234
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation pending.
Event or Problem Description
The customer reported receiving false positive coc, mamp, and thc results on both staff and patients.The false positive results occurred on 75 devices out of 75 devices used.No confirmatory testing was performed and no adverse patient outcomes reported.
Additional Manufacturer Narrative
Retention and return products were tested with in-house, drug-free donor urine.All devices produced expected negative results at read time, indicated by distinct negative test lines for all analytes, including coc, mamp, and thc.The reported complaint of false positive results was not replicated during in-house testing.Manufacturing batch record review for the reported lot number did not uncover any abnormalities and all quality control specifications were met.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

• Brand Name: MULTI-DRUG 3 PANEL SCREEN TEST
• Common Device Name: ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 7883314
• Report Number: 2027969-2018-00120
• Device Sequence Number: 1908923
• Product Code: DIO
• UDI-Device Identifier: 10858904006201
• UDI-Public: (01)10858904006201(17)190430(10)DOA7040467
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K061718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: DOA-234
• Device Lot Number: DOA7040467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1